Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life (PREV-IX_B)
- That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels, lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of age.
- That infants receiving PCV13 as a booster at 13 months of age, compared to controls having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes 3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation at 18 and 36 months of age.
Lower Respiratory Tract Infection
Upper Respiratory Tract Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Pneumococcal Conjugate Vaccine (PCV) Schedules for the Northern Territory (NT): Randomised Controlled Trial of Booster Vaccines to Broaden and Strengthen Protection From Invasive and Mucosal Infections.|
- Immune response [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]The primary outcome will be the proportion of subjects with serotype-specific antibody above the level required for protection from IPD in each study group at 18 months of age, 5 months after the booster dose. This will be determined in ELISA assays.
- Nasopharyngeal carriage [ Time Frame: At 13, 18 and 36 months of age ] [ Designated as safety issue: No ]At baseline (13 mo), 18 and 36 months of age, the proportion of children with a any carriage of serotype 3, 6A and 19A pneumococci b any carriage of any NTHi
- Otitis media [ Time Frame: At 13, 18 and 36 months of age ] [ Designated as safety issue: No ]At baseline (13 mo), 18 and 36 months of age, the proportion of children with c any otitis media. d any tympanic membrane perforation
- Episodes of respiratory illness and acute otitis media [ Time Frame: Between baseline (13 mo) and 36 months of age ] [ Designated as safety issue: No ]Between baseline (13 mo) and 36 months of age Episodes of respiratory illness and acute otitis media
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
The booster dose of Prevenar13 is 0.5 mL given intramuscularly only, with care to avoid injection into or near nerves and blood vessels. The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.
Each 0.5 mL dose contains:
2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg).
The booster vaccination schedule consists of one dose of 0.5 ml with an interval of at least 1 month between doses.
The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01735084
|Australia, Northern Territory|
|Menzies School of Health Research|
|Darwin, Northern Territory, Australia, 0810|
|Principal Investigator:||Amanda J Leach, PhD||Menzies School of Health Research|